Alliance for Clinical Trials in Oncology
This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.
PRIMARY OBJECTIVES: I. To determine maximum tolerated dose (MTD) of iberdomide (CC-220) in combination with belantamab mafodotin and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM). (PHASE I) II. To determine whether the combination of belantamab mafodotin/ iberdomide/dexamethasone improves progression-free survival (PFS) relative to belantamab mafodotin/dexamethasone in patients with RRMM. (PHASE II) SECONDARY OBJECTIVES: I. To summarize the incidence and cause for treatment delays, modifications and omissions. (PHASE I) II. To assess treatment response. (PHAS…
* Documentation of disease: Diagnosis of multiple myeloma and have relapsed or refractory disease according to the IMWG criteria where: * Progression of myeloma is defined by IMWG criteria as recurrence of disease after prior response, indicated as any of the following: * ≥ 25% increase in M-protein (must be at least 0.5g/dl above nadir from last treatment regimen). * 25% difference between involved and uninvolved serum free light chains from its nadir or * The development of new plasmacytomas or hypercalcemia. * Refractory myeloma as defined by IMWG criteria as disease which…
Receive PO
Receive IV
Receive PO
Undergo ECHO
Undergo CT
Undergo MRI
Undergo PET
Undergo Bone Marrow Biopsy
Undergo Bone Marrow Aspirate
Undergo blood sample collection